CLINICAL TRIALS PROFILE FOR CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

All Clinical Trials for CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01132443 ↗	W0261-101: A Phase 1, Single Center, Randomized, Open-Label Study to Evaluate the Bioavailability of Clindamycin From Clindamycin 1%-Benzoyl Peroxide 3% Gel, Topical Gel (Clindamycin 1%- Benzoyl Peroxide 5%), and Once Daily Gel (Clindamycin 1%-Benzo	Completed	GlaxoSmithKline	Phase 1	2010-05-06	This study was conducted to determine if the bioavailability of clindamycin and its metabolite clindamycin sulfoxide are altered by the concentration of BPO or the absence of methylparaben. This study compared the investigational study product and 2 marketed products: - CLN 1%-BPO 3% Gel (clindamycin 1%-BPO 3%), methylparaben-free - Topical Gel (clindamycin 1%-BPO 5%), methylparaben-preserved (Topical Gel-MP) - Once Daily Gel ((clindamycin 1%-BPO 5%), methylparaben-free (Topical Gel-MPF)
NCT01015638 ↗	Compare the Tolerance of Clindamycin 1% /Benzoyl Peroxide (BPO) 5% Gel to Clindamycin 1.2%/ BPO 2.5% Topical Medications	Completed	GlaxoSmithKline	Phase 4	2009-08-01	This is a single-blind (blinded expert grader) study that will enroll 25-30 healthy volunteers without facial acne. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide 5% or clindamycin phosphate and benzoyl peroxide 2.5% and the other side of the face will remain non-treated to serve as a control.
NCT01015638 ↗	Compare the Tolerance of Clindamycin 1% /Benzoyl Peroxide (BPO) 5% Gel to Clindamycin 1.2%/ BPO 2.5% Topical Medications	Completed	Stiefel, a GSK Company	Phase 4	2009-08-01	This is a single-blind (blinded expert grader) study that will enroll 25-30 healthy volunteers without facial acne. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide 5% or clindamycin phosphate and benzoyl peroxide 2.5% and the other side of the face will remain non-treated to serve as a control.
NCT00807014 ↗	Evaluation of Quality of Life, Efficacy, and Tolerance of Duac® Gel Compared to Differin® Gel in the Treatment of Acne	Completed	GlaxoSmithKline	Phase 4	2006-11-01	The objectives of this clinical trial are to compare the quality of life of the subjects, the efficacy and the tolerance of Duac® Gel (gel formulation with a combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide), applied once daily, against Differin® Gel (gel with 0.1% adapalene), used once daily, in the treatment of mild to moderate acne vulgaris.
NCT00807014 ↗	Evaluation of Quality of Life, Efficacy, and Tolerance of Duac® Gel Compared to Differin® Gel in the Treatment of Acne	Completed	Stiefel, a GSK Company	Phase 4	2006-11-01	The objectives of this clinical trial are to compare the quality of life of the subjects, the efficacy and the tolerance of Duac® Gel (gel formulation with a combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide), applied once daily, against Differin® Gel (gel with 0.1% adapalene), used once daily, in the treatment of mild to moderate acne vulgaris.
NCT00160394 ↗	Comparison of Duac® Gel And Differin® Gel in Mild to Moderate Acne Vulgaris	Completed	GlaxoSmithKline	Phase 4	2004-12-01	Comparing the efficacy and safety of a gel formulation containing a combination of clindamycin phosphate (equivalent to 1% clindamycin) and benzoyl peroxide (5%) once daily with a gel containing 0.1% adapalene once daily in the treatment of acne vulgaris of mild to moderate severity.
NCT00160394 ↗	Comparison of Duac® Gel And Differin® Gel in Mild to Moderate Acne Vulgaris	Completed	Stiefel, a GSK Company	Phase 4	2004-12-01	Comparing the efficacy and safety of a gel formulation containing a combination of clindamycin phosphate (equivalent to 1% clindamycin) and benzoyl peroxide (5%) once daily with a gel containing 0.1% adapalene once daily in the treatment of acne vulgaris of mild to moderate severity.

Clinical Trial Conditions for CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

Condition Name

Condition Name for CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Intervention	Trials
Acne Vulgaris	10
Acne	1
Actinic Keratosis	1

Condition MeSH

Condition MeSH for CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Intervention	Trials
Acne Vulgaris	11
Keratosis, Actinic	1
Keratosis	1

Clinical Trial Locations for CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

Trials by Country

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Trials by Country for CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Location	Trials
United States	13
India	10
China	9
Poland	1
Spain	1

Trials by US State

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−

Trials by US State for CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Location	Trials
New York	3
Pennsylvania	2
Texas	1
New Mexico	1
Nebraska	1

Clinical Trial Progress for CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

Clinical Trial Phase

Clinical Trial Phase for CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	4
Phase 2	1

Clinical Trial Status

Clinical Trial Status for CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Clinical Trial Phase	Trials
Completed	10
Unknown status	2

Clinical Trial Sponsors for CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

Sponsor Name

Sponsor Name for CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Sponsor	Trials
GlaxoSmithKline	5
Stiefel, a GSK Company	4
Zeichner, Joshua, M.D.	2

Sponsor Type

Sponsor Type for CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Sponsor	Trials
Industry	16
Other	3

Clinical Trials, Market Analysis, and Projections for Clindamycin Phosphate and Benzoyl Peroxide

Clinical Trials Update

Efficacy and Safety of Triple-Combination Therapy

A significant clinical trial has been conducted to evaluate the efficacy and safety of a triple-combination, fixed-dose topical gel containing clindamycin phosphate 1.2%, benzoyl peroxide (BPO) 3.1%, and adapalene 0.15% (IDP-126) for the treatment of acne. This phase II, double-blind, multicenter, randomized study involved 741 participants with moderate-to-severe acne, aged 9 years and older.

• Outcomes: The results showed that 52.5% of participants treated with IDP-126 achieved treatment success, defined as a ≥ 2-grade reduction from baseline in the Evaluator's Global Severity Score and clear/almost clear skin, compared to 8.1% for the vehicle group and 27.8-30.5% for the dyad component gels. IDP-126 also resulted in significant reductions in both inflammatory and noninflammatory lesion counts, exceeding 70% reductions[1].

• Safety and Tolerability: The treatment was well tolerated, with most treatment-emergent adverse events being mild to moderate in severity[1].

Mechanism of Action

Each component of the triple-combination therapy plays a distinct role:

• Clindamycin Phosphate: Targets the 23S RNA subunit of bacteria, inhibiting protein synthesis and reducing bacterial growth[3].
• Benzoyl Peroxide: Acts as an antimicrobial agent, breaking down comedones and increasing epithelial cell turnover. It generates free radicals that interact with bacterial proteins, reducing keratin and sebum around follicles[4].
• Adapalene: A naphthoic acid derivative that targets specific retinoic acid nuclear receptors, promoting cell turnover and preventing the formation of comedones[3].

Market Analysis

Current Market Size and Forecast

The global market for Clindamycin Phosphate and Benzoyl Peroxide was estimated to be worth US$ 214 million in 2023. It is projected to grow to US$ 322.8 million by 2030, with a Compound Annual Growth Rate (CAGR) of 6.2% during the forecast period of 2024-2030[2][5].

Key Players

The market is dominated by several major pharmaceutical companies, including:

• Bausch Health
• Perrigo
• Mylan
• Tolmar
• TARO
• GSK[2].

Market Segmentation

The market is segmented based on type and application:

• Types: The market includes various concentrations such as 1.2%/2.5%, 1.2%/3.75%, 1%/5%, and 1%/3% combinations of Clindamycin Phosphate and Benzoyl Peroxide[2][5].
• Applications: The primary applications are in hospitals and drug stores[2][5].

Driving Factors

Increasing Demand for Personalized Skincare Solutions

The rising demand for personalized skincare solutions is a significant driver for the Clindamycin Phosphate and Benzoyl Peroxide market. Consumers are increasingly seeking tailored treatments that address their specific skin concerns, including acne[5].

Advancements in Drug Delivery Technologies

Advancements in drug delivery technologies have improved the efficacy and tolerability of topical treatments. These innovations enhance the penetration and stability of the active ingredients, making the treatments more effective and user-friendly[5].

Market Projections

Growth Prospects

The market is expected to continue growing due to the increasing prevalence of acne and the need for effective, well-tolerated treatments. The CAGR of 6.2% indicates a steady and robust growth trajectory over the next several years[2][5].

Regional Outlook

While the global market is expanding, regional variations in market size and growth rates are influenced by factors such as healthcare infrastructure, consumer awareness, and regulatory environments. Developed regions are expected to drive significant growth, but emerging markets are also showing promising potential[2].

Key Takeaways

• Clinical Efficacy: The triple-combination therapy of Clindamycin Phosphate, Benzoyl Peroxide, and Adapalene has demonstrated superior efficacy and tolerability in clinical trials.
• Market Growth: The global market for Clindamycin Phosphate and Benzoyl Peroxide is projected to reach US$ 322.8 million by 2030, with a CAGR of 6.2%.
• Driving Factors: Increasing demand for personalized skincare solutions and advancements in drug delivery technologies are key drivers of market growth.
• Market Segmentation: The market is segmented by type and application, with major players including Bausch Health, Perrigo, and others.

FAQs

What is the projected market size for Clindamycin Phosphate and Benzoyl Peroxide by 2030?

The global market for Clindamycin Phosphate and Benzoyl Peroxide is expected to reach US$ 322.8 million by 2030[2][5].

What is the CAGR for the Clindamycin Phosphate and Benzoyl Peroxide market from 2024 to 2030?

The market is expected to exhibit a CAGR of 6.2% during the forecast period of 2024-2030[2][5].

Who are the main players in the Clindamycin Phosphate and Benzoyl Peroxide market?

The main players include Bausch Health, Perrigo, Mylan, Tolmar, TARO, and GSK[2].

What are the primary applications of Clindamycin Phosphate and Benzoyl Peroxide?

The primary applications are in hospitals and drug stores[2][5].

How does the triple-combination therapy of Clindamycin Phosphate, Benzoyl Peroxide, and Adapalene work?

Each component targets different aspects of acne pathogenesis: Clindamycin Phosphate inhibits bacterial growth, Benzoyl Peroxide reduces keratin and sebum, and Adapalene promotes cell turnover and prevents comedone formation[1][3][4].

Sources

1. Efficacy and Safety of a Fixed-Dose Clindamycin Phosphate 1.2%/Benzoyl Peroxide 3.1%/Adapalene 0.15% Gel for the Treatment of Acne. PubMed, 2021.
2. Clindamycin Phosphate and Benzoyl Peroxide - Market Size. Valuates Reports.
3. Net Present Value Model: (Adapalene + Benzoyl Peroxide + Clindamycin Phosphate). GlobalData.
4. Benzoyl Peroxide: Uses, Interactions, Mechanism of Action. DrugBank.
5. Clindamycin Phosphate and Benzoyl Peroxide Market 2032. Business Research Insights.